510(k) K163357
- Device
- OneTouch Via On-Demand Insulin Delivery System
- Applicant
- LifeScan Europe, A Division Of Cilag GmbH
- 510(k) number
- K163357
- Product code
- OPP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-07
- Date received
- 2016-11-30
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Insulin Bolus
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kirsten Franco
- Address
- Gubelstrasse 34 Zug CH Ch-6300 Ch-6300
FDA Registration Numbers#
- 1721676
- 1000165286
- 2246552
- 3015218509
- 1047843
- 3007871880
Source Documents#
Other 510(k) Records For Product Code OPP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252757 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2026-04-10 |
| K243273 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024-11-13 |
| K233447 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024-01-18 |
| K111924 | FINESSE PERSONAL INSULIN DELIVERY PATCH | Calibra Medical, Inc. | 2012-04-10 |
| K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Calibra Medical, Inc. | 2010-06-28 |
| K093065 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | Calibra Medical, Inc. | 2010-01-20 |
Legacy Summary#
summary
FDA Review#
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